Status:
UNKNOWN
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
To compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan criteria BCLC stage A/B HCC who underwent hepatectomy.
Eligibility Criteria
Inclusion
- older than 18 years old and younger than 75 years;
- ECOG PS≤1;
- proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- not previous treated for tumor;
- the tumor was diagnosed as BCLC stage A/B and beyond Milan criteria;
- no distant metastasis;
- the lab test could meet:
- neutrophil count≥2.0×109/L;
- hemoglobin≥100g/L;
- platelet count≥75×109/L;
- serum albumin≥35g/L;
- total bilirubin\<2-times upper limit of normal;
- ALT\<3-times upper limit of normal;
- AST\<3-times upper limit of normal;
- serum creatine\<1.5-times upper limit of normal;
- PT≤upper limit of normal plus 4 seconds;
- INR≤2.2;
- sign up consent.
Exclusion
- cannot tolerate TAI or surgery;
- distant metastasis exits;
- known history of other malignancy;
- be allergic to related drugs;
- underwent organ transplantation before;
- be treated before (interferon included);
- known history of HIV infection;
- known history of drug or alcohol abuse;
- have GI hemorrhage or cardiac/brain vascular events within 30 days;
- pregnancy.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT03851913
Start Date
July 1 2018
End Date
August 31 2024
Last Update
November 29 2019
Active Locations (1)
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1
SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, China, 510060